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DocuSign Envelope ID: C9E26C4D-6C1E A-F86C07868EC4. Capsule Endoscope. Installation & Software User Guide

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Capsule Endoscope

Installation & Software

User Guide

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MIROCAM®, MIROVIEW™ are trademarks and registered trademarks of IntroMedic, Co., Ltd.

© 2014 Medivators Inc. 50098-695 Rev A

All rights reserved. This publication is protected by copyright. Copying, disclosure to others, or the use of this publication is prohibited without the express written consent of Medivators Inc.

MEDIVATORS reserves the right to make changes in the specifications shown herein without notice or obligation. Contact your MEDIVATORS representative or MEDIVATORS customer service for more information

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Table of Contents

Overview

... 5

Purpose ... 5

About MIROCAM® Capsule Endoscope ... 5

About MIROVIEW™ ... 5

Installation

... 7

User Account Control ... 7

Standalone Installation ... 9

Customized Installation (Multi-PC) ... 15

Atlas Drive Patch ... 20

MIROVIEW Operator

... 23

Import / Export Case Files ... 23

Backing up Case Files ... 27

MIROVIEW Client

... 29

Printing Reports ... 29

Save Report as a PDF ... 31

Review Mode ... 33

Review Mode Features ... 33

Report Mode ... 37

Report Mode Features ... 38

Export Mode ... 41

Export Mode Features ... 41

M

IROVIEW Atlas

... 43

Atlas ... 43

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Overview

Purpose

The purpose of this guide is to help the user to better understand the MIROVIEW™ software and to better utilize its functions. This guide is specifically made for the usage of MIROVIEW 2.0 including installation and procedural use. It does not contain troubleshooting information, please refer to the Troubleshooting Guide or call MEDIVATORS Technical Support for further assistance.

About MIROCAM

®

Capsule Endoscope

MIROCAM Capsule Endoscope has the diameter and length of 11x24 mm and is intended for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule containing a light source, camera, transmitter, and battery.

MIROCAM Capsule Endoscope has the longest operation time of more than 11hours. Longest operation time ensures images of entire small bowel and also able to capture colon images. The MIROCAM Capsule endoscope procedure is a safe and patient friendly procedure and the patient can go about a normal daily life.

About MIROVIEW

MIROVIEW is the software used with MIROCAM Capsule Endoscope to view the footage captured by the device post-procedure. The software has been significantly enhanced through new features and design, including interoperability with PACS system and network support.

The software includes an enhanced interface which gives a more comfortable user experience, a reporting tool with enhanced design and new features simplifying the reporting process, express view which is a second generation quick view mode to streamline the review process, range view and map view to help assist with identifying GI landmarks more readily, and drag bag which enables the gathering of desired images in designated folders created by the user for faster diagnosis. The drag bag function also assists in faster landmark placement with a simple click and drag motion.

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Installation

User Account Control

It is compulsory to disable the User Account Setting to install MIROVIEW™ successfully. 1. Go to ‘Control Panel’ and click ‘User Accounts’.

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Standalone Installation

Minimum server requirements:

• User Account Control (UAC) OFF • Windows Vista or 7 (32 & 64 bit) • CPU: Core 2 Duo E6300 • 4GB RAM and 1TB Hard Drive • Video 1024x768

Must be logged in with local admin rights!

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2. Close the “Cautions” WordPad window.

3. Click ‘Next’.

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5. Select ‘Complete’ then click ‘Next’.

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7. The receiver device drivers then get installed.

NOTE:You will go through the following install wizard twice.

8. Clink ‘Install’. If you click the box to ‘Trust IntroMedic Co. Ltd.’ you will not get prompted again.

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10. Click ‘Finish’.

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12. Run ‘MIROVIEW™ Server’. a. IP Address is “localhost” b. Port is 2000

c. Set password

d. Set path to the drive with the greatest space for saving files e. Scroll down and fill out the remaining fields

f. Click ‘Save’

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Customized Installation (Multi-PC)

Installation Prerequisites required for EACH computer:

• User Admin Rights (Shut off UAC, directions from Standalone Install) • 32 or 64 bit operating system

• Static IP Address that will be assigned to the MIROVIEW™ Server • MIROVIEW Server software must remaining to access data

• All installations must be logged into with an account that has User Admin Rights 1. MIROVIEW Server must be installed and configured first. Select ‘Custom Install’.

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2. Select the ‘MIROVIEW™ Server’ checkbox ONLY.

3. REBOOT after installation. 4. Run ‘MIROVIEW Server’

a. IP Address is “localhost” b. Port is 2000

c. Set password

d. Set path to the drive with the greatest space for saving files e. Scroll down and fill out the remaining fields

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5. MIROVIEW™ Operator Install also requires a ‘Custom Install’.

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7. Complete the installation

8. Run ‘MIROVIEW™ Operator’

a. IP Address is the Static IP Address assigned to the server b. Port is 2000

c. Set path to drive with the greatest space for saving files d. Click ‘Save’

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10. Select the ‘MIROVIEW™ Client’, ‘Atlas’, and ‘Viewer’ checkboxes 11. Complete the installation

12. Run ‘MIROVIEW Client’

a. IP Address is the Static IP Address assigned to the server b. Port is 2000

c. Set path to drive with the greatest space for saving files d. Click ‘Save’

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Atlas Drive Patch

This is required for both 32 and 64 bit machines. 32 bit can use the Atlas Patch program, but 64 bit machines will need to be patched manually. Contact MEDIVATORS Customer Support if you need the patch file.

64 bit Manual Patch Directions:

1. Run ‘regedit.exe’.

2. Double-click HKEY_LOCAL_MACHINE 3. Double-click SOFTWARE

4. Double-click Wow6432Node

5. Double-click IntroMedic > MIROVIEW™ > 2.0 6. Select Atlas

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7. Double-click ConfigExist and set to 0

8. Double-click HKEY_CURRENT_USER

9. Double-click Software

10. Double-click IntroMedic > MIROVIEW™ > 2.0 11. Select Atlas

12. Set Active Video Path and Local File Path from D:\ to C:\ 13. Run MIROVIEW Client

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MIROVIEW™ Operator

This software is used to upload/ import/ export case files and utilize the MIROCAM® Capsule Endoscope receivers. When

a case file is uploaded to Operator with a Multi-PC set up, the case file can be viewed on other operator/ client machines on the network.

NOTE: You can do all of these in MIROVIEW Client. The only difference between MIROVIEW Operator and MIROVIEW Client is that MIROVIEW Operator can initialize and set up receivers.

Import/ Export Case Files

This function allows the user to export/ import case files to / from a removable media device or other storage location. NOTE: Case files are approximately 3GB in size.

Importing a Case File

1. Open ‘MIROVIEW Operator’.

2. Select ‘List > Import Case/ Review File… > Import Case’.

3. Select the .mec file from the storage location. 4. Click ‘Import’.

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5. A ‘Task Manager’ window should open with the import status.

6. Once the file has been imported it should be visible on the ‘List’ screen, and the ‘Task Manager’ status should say ‘Complete’.

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Exporting a Case File

1. Select the case file(s) you wish to export.

2. Select ‘List > Export Selected Case(s)’.

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4. A ‘Task Manager’ window should open with the export status.

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Backing up Case Files

This tool is so the user can safely back up important case files to a different location to ensure that it does not get deleted on accident, or disappears if something happens with the MIROVIEW™ software.

1. Select the case file(s) you wish to backup.

2. Select ‘List > Backup Selected Case(s) > (Select storage DVD or General)’. NOTE: General is for any external USB media or a location on the machine.

3. If ‘DVD’ is selected a ‘Task Manager’ screen with automatically pop up. If ‘General’ is selected a ‘Browse to Folder’ screen will open.

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4. Select the backup location and click ‘OK’.

5. A ‘Task Manager’ window should open with the backup status. NOTE: If exporting to ‘DVD’ this window will open straight away.

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MIROVIEW™ Client

This is the viewing software for MIROCAM® Capsule Endoscope. It allows the user to review the case file(s) in different

ways. You can also create reports using this software and save them in PDF format.

Printing Reports

This selection allows the user to print out a report of the case file(s) selected in the MIROVIEW Client list screen. 1. Select the case file(s) you wish to create a report with.

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3. Select the ‘Print Options’ to include, and the ‘Layout’ of the report. 4. Click ‘OK’.

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Save Report as a PDF

This selection allows the user to save the case file report(s) to a PDF format instead of printing. 1. Select the case file(s) you wish to save.

2. Select ‘List > Save Report as PDF for Selected Case(s)…’.

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4. Select the location you wish to save the PDF.

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Review Mode

This tab allows the user to review the selected case file.

Review Mode Features

These features make it easier for the user to view the case file(s) in a timely manner while also capturing images for reporting purposes.

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View Mode:

• Single View – Single image in the center • Dual View – Two images next to each other • Quad View – Four images in a square

• Range View – Nine images before and after the center image

• Map View – The entire reel of images in a line on the screen, the user can hover over the line to view the images

Play Mode:

Normal Play – Shows all images captured by the MIROCAM® Capsule Endoscope

Express Play – Hides similar images that have no change in them to shorten the viewing time • SGIB Play

Play Buttons:

In order from left to right – Play Reverse, Play, Play

Capture:

• Allows the user to capture a specific image and add it to a list for later use in reporting.

Landmark:

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Image Enhancement:

• Allows the user to change the image coloring to better see images and get a better idea if a slide contains a diagnosis or not using the ALICE feature.

Findings Summery Box:

• Allows the user to see the captured images and sort them based on what was seen in the image. Also includes the location of the body that the image was found in.

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Comparison Mode:

• Allows the user the ability to compare an image found to a known, diagnosed image in Atlas.

Thumbnail Extension:

• Allows the user to view the images in thumbnail form. Also makes it easier for the user to mass select images to be captured.

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Report Mode

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Report Mode Features

These features make it easier for the user to write, enhance and edit captured images so they are easier to read when the report is created for the case file(s).

Circumference Markers:

• Allows the user to add circumference lines to the main image to easily show where the issue is in the image by sectioning it off. (Purple lines in image below)

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Drawing Tools:

(In order from left to right) • Draw Circle • Draw Line • Eraser • Color Palette • Undo • Redo

Image Enhancement:

• Same feature as described under ‘Review Mode Features’.

Findings:

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Image Comments:

• Allows the user to add comments to a specific image. Also give the ability to add a voice recording to the image.

GI Dictionary:

• Allows the user to add commonly used words for reports into an easy dictionary, where the user can select a word and then click the ‘Input Selected Word’ button to add that word to the ‘Image Comments’ section. This tool also helps with repeat spelling errors on reports.

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Export Mode

This tab gives the user the ability to save, print and export the case file after it has been edited and viewed.

Export Mode Features

These features make it quick and easy for the user to print the report, save the report to a PDF file or even export the case file(s) elsewhere for use.

Data to Include:

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Print and Save Options:

Print – Allows the user to print the report created

Preview – Allows the user to preview the report before printing

Save to PDF – Allows the user to save the report to a PDF file instead of printing • Export Review – Allows the user to review the report before exporting it

Export Options:

• Export Captured Images with EXMIF

• Export Captured Images as Image/ Video/ MIROVIDEO • Export Segments as Video/ MIROVIDEO

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MIROVIEW™ Atlas

This software is used as a comparison tool for users so they can compare images from their MIROCAM® Capsule

Endoscope trials and determine a diagnosis. Atlas is used only as a comparison tool and should not be used to confirm a specific diagnosis, only a certified medical professional can.

Atlas

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My Atlas

This tab allows the user to create their own comparison guide based on their own trials and images found from them.

Import Atlas Images from File:

• Allows the user to add their images to the My Atlas catalog.

NOTE: For additional assistance using MIROVIEW™ Atlas got to ‘Help > User Guide’.

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www.medivators.com

Manufactured in the USA by:

Medivators Inc. 14605 28th Avenue North Minneapolis, MN 55447 USA Toll Free: +1.800.444.4729 Medivators BV Sourethweg 11 6422PC Heerlen The Netherlands Tel: +31.45.5.471.471

Cantel Medical Asia/Pacific Pte. Ltd. 1A International Business Park #05-01 Singapore 609933 Tel: +65.6227.9698

Medivators Inc. Beijing Representative Office

Room 1801, Floor 18th, Tower A,

Beijing Marriott Hotel, Office Building

No. 7, Jianguomen South Avenue,

Dongcheng District, Beijing 100005 China

Tel: +86 10 65204039

References

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